Safety and Initial Efficacy Study of the Vortx Rx for Treatment of Benign Prostatic Hyperplasia (US)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01896973|
Recruitment Status : Active, not recruiting
First Posted : July 11, 2013
Last Update Posted : February 23, 2017
|Condition or disease||Intervention/treatment||Phase|
|Benign Prostatic Hyperplasia (BPH)||Device: Vortx Rx - Histotripsy BPH Device||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||35 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Safety and Initial Efficacy Study of the Vortx Rx for Treatment of Benign Prostatic Hyperplasia (US)|
|Study Start Date :||July 2013|
|Actual Primary Completion Date :||December 2016|
|Estimated Study Completion Date :||December 2020|
Experimental: Vortx Rx - Histotripsy BPH Device
The Vortx Rx is a portable ultrasound therapy device system that is intended for the treatment of BPH by using very intense, low duty-cycle ultrasound pulses to debulk prostatic tissue.
Device: Vortx Rx - Histotripsy BPH Device
Non-invasive histotripsy treatment/therapy to be delivered by the surgeon using very low duty cycle ultrasound pulses from outside the patient's body. These pulses form a bubble cloud at the end of the focal area within the prostate which mechanically breaks up the cellular structure of the soft tissue. During treatment, a surgeon is able to direct the bubble cloud throughout the targeted volume using controls located on the device console and using the real-time ultrasound for visualization feedback and control of the bubble cloud location.
- Safety of the Vortx Rx for treatment of symptomatic BPH [ Time Frame: 1 Day, 1, 3 and 6 months ]
- Record and report all adverse events.
- Determine rate of occurrence of adverse events, serious adverse events and device-related adverse events as a measure of safety and as factors used to determine study success.
- Initial prostate histotripsy treatment efficacy [ Time Frame: 1, 3 and 6 months ]
- Change in LUTS as measured by International Prostate Symptom Score (IPSS), uroflow (Qmax), post-void residual (PVR). Each to be measured at 1, 3 and 6 months.
- Change in prostate parenchymal volume (TRUS and prostate-specific antigen [PSA]). TRUS to be performed at end of treatment and at 6 months post-treatment. PSA to be tested 6 months post-treatment.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01896973
|United States, Michigan|
|Univerisity of Michigan|
|Ann Arbor, Michigan, United States, 48109|
|United States, Ohio|
|ProMedica Parkway Surgery Center|
|Toledo, Ohio, United States, 43606|
|Principal Investigator:||Timonthy Schuster, MD||ProMedica Parkway Surgery Center|
|Principal Investigator:||John Wei, MD||University of Michigan|